摘要
Objective To evaluate the efficacy and safety of Huanglian Wendan Decoction(黄连温胆汤,HLWDD)alone or combined with western medicine in treating insomnia caused by phlegm-heat internal disturbance in recent 10 years.Methods The randomized controlled trials of HLWDD alone or combined with western medicine in treating insomnia caused by phlegm-heat internal disturbance from January 1,2012 to April 1,2022 were searched in China National Knowledge Infrastructure(CNKI),China Science and Technology Journal Database(VIP),Wanfang Database,China BioMedical Literature Database(CBM),PubMed,Web of Science,Embase,and Cochrane Library databases.After being screening,the included literature was analyzed to evaluate the effective rate,Pittsburgh Sleep Quality Index(PSQI)score,traditional Chinese medicine(TCM)syndrome score,and adverse reactions of HLWDD on insomnia caused by phlegm-heat internal disturbance.The subgroup analyzed the effect of HLWDD after different treatment courses,and compared the therapeutic effects of HLWDD alone and HLWDD combined with western medicine.Results Twenty-seven randomized controlled trials were finally included,with a total of 2395 patients.The results of the meta-analysis showed that the curative effect of HLWDD alone or combined with the western medicine group was better than that of the western medicine group[RR=1.14,95%CI(1.06,1.22),P=0.000].The PSQI score[SMD=-0.31,95%CI(-0.42,-0.20),P=0.000],TCM syndrome score[SMD=-0.40,95%CI(-0.67,-0.12),P=0.005],and adverse reaction rate[RR=0.21,95%CI(0.15,0.29),P=0.000]of HLWDD alone or combined with western medicine group were significantly reduced compared with the western medicine group.The subgroup’s analysis showed that the curative effect of HLWDD alone or combined with western medicine group of 4 weeks treatment course was better than that of the western medicine group[RR=1.14,95%CI(1.03,1.26),P<0.05].The TCM syndrome score of HLWDD alone or combined with the western medicine group of 4 weeks treatment course decreased more obviously than t
目的对近10年来报道的黄连温胆汤单独或联合西药治疗痰热内扰型失眠的有效性及安全性进行评估。方法在中国知网、维普、万方、中国生物医学数据库、PubMed、Web of science、Embase和Cochrane Library数据库中检索自2012年1月1日至2022年4月1日黄连温胆汤单独或联合西药治疗痰热内扰型失眠的随机对照试验。经筛选后对纳入文献进行分析,评估黄连温胆汤对痰热内扰型失眠的有效率、匹茨堡睡眠质量指数量表(PSQI)评分、中医证候积分及不良反应的影响。亚组分析黄连温胆汤治疗不同时间后的效果,比较单独使用黄连温胆汤与黄连温胆汤联合西药治疗的效果。结果最终纳入27篇随机对照试验,共计2395例患者。Meta分析结果显示黄连温胆汤单独或联合西药组对比西药组疗效更好[RR=1.14,95%CI(1.06,1.22),P=0.000],黄连温胆汤单独或联合西药组对比西药组PSQI评分[SMD=-0.31,95%CI(-0.42,-0.20),P=0.000]、中医证候积分[SMD=-0.40,95%CI(-0.67,-0.12),P=0.005]、不良反应率[RR=0.21,95%CI(0.15,0.29),P=0.000]显著降低。亚组分析显示黄连温胆汤单独或联合西药组对比西药组,治疗4周疗效更好[RR=1.14,95%CI(1.03,1.26),P<0.05];黄连温胆汤单独或联合西药组对比西药组,疗程为4周时,中医症候积分降低更明显[SMD=-0.60,95%CI(-0.96,-0.25),P<0.05];黄连温胆汤单独或联合西药组对比西药组在治疗周期上与PSQI积分、不良反应率无明显相关性。单独使用黄连温胆汤组与西药组相比有效率[RR=1.09,95%CI(1.00,1.23),P<0.05]较于黄连温胆汤联合西药组对比西药组有效率[RR=1.15,95%CI(1.03,1.29),P<0.05)效果相同;黄连温胆汤联合西药组对比西药组PSQI积分[SMD=-0.44,95%CI(-0.59,-0.30),P<0.05]、中医症候积分[SMD=-1.10,95%CI(-1.59,-0.61),P<0.05]显著降低;单独使用黄连温胆汤不良反应发生率[RR=0.08,95%CI(0.04,0.17),P<0.05]与黄连温胆汤联合西药治疗不良反应发生率[RR=0.36,95%C
基金
Basic Research Fund Project of the Central Public Welfare Research Institute of China Academy of Chinese Medical Sciences(Zz13-zd-09).
